Trials / Completed
CompletedNCT00228449
Peginesatide for Anemia in Chronic Hemodialysis Patients
A Phase 2, Open-label, Multi-center, Sequential, Dose Finding Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Peginesatide Administered Intravenously for the Maintenance Treatment of Anemia in Chronic Hemodialysis Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Affymax · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple intravenous doses of peginesatide in participants with chronic kidney disease (CKD) who are on hemodialysis.
Detailed description
This was a Phase 2, multicenter, open-label, sequential, dose-finding trial designed with up to 12 treatment cohorts of 15 participants per cohort. Each participant received an intravenous dose of peginesatide administered once every 4 weeks (Q4W) for a total of 6 doses. Dosage regimens varied by cohort. Participants were followed for a minimum of 42 days after the last administration of peginesatide.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | peginesatide |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2007-05-01
- Completion
- 2007-05-01
- First posted
- 2005-09-29
- Last updated
- 2012-12-21
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00228449. Inclusion in this directory is not an endorsement.